Kelvi KLV20004Recalls & reported problems
Hypothermia Devices, Inc. · Kelvi Ankle Pro Smart Wrap · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850001185059), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Excessive Heating” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Excessive Heating1
Patient problems
- Blister1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2022Excessive Heating; Excessive Heating
ATHLETE DEVELOPED A BLISTER APPROXIMATELY ONE INCH IN DIAMETER ON THE LATERAL PART OF THE RIGHT ANKLE WHILE USING A CONTRAST PROTOCOL. THE BLISTER HEALED FULLY AND THE PATIENT REQUIRED NO OUTSIDE MEDICAL INTERVENTION.
Patient problems: Blister
MAUDE report 15919839 ↗
Other Pack, Hot Or Cold, Water Circulating devices
- DONJOY 11-1422Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-0494Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- Electri-Cool ll 767Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- DONJOY 11-1424Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- DONJOY 11-9099Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- T/Pump TP700Stryker Corporation · Pack, hot or cold, water circulating15 reports
- Mul-T-Pad 8002-062-026Stryker Corporation · Pack, hot or cold, water circulating7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page